FDA Device Intelligence
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Dilator, Esophageal

FDA product code KNQ · Class 2 · Gastroenterology, Urology

632
Registered devices
5,224
Adverse events
21
Recalls
40
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-03-18Diversatek HealthcareThe catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each st
2026-03-18Diversatek HealthcareThe catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each st
2026-03-18Diversatek HealthcareThe catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each st
2026-03-18Diversatek HealthcareThe catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each st
2013-05-28Boston Scientific CorporationProduct labeled with incorrect expiration date.
2007-04-16Conmed Endoscopic Technologies, Inc.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16Conmed Endoscopic Technologies, Inc.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16Conmed Endoscopic Technologies, Inc.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16Conmed Endoscopic Technologies, Inc.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
2007-04-16Conmed Endoscopic Technologies, Inc.Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.